Order amending and supplementing the Order No. 69 of 2006 on the requirements for good manufacturing practice in the production of veterinary medicinal products and active substances.
Country
Type of law
Regulation
Abstract
This Order amends various provisions part of the Order No. 69 of 2006 on the requirements for good manufacturing practice in the production of veterinary medicinal products and active substances (originally published in the Official Gazette of the Republic of Bulgaria 49/2006, and already amended in Gazettes 6 and 85 year 2010, 66/2011, 91/2014, 32/2017, 48/2019 and 104/2023). Changes are concerning several technical issues, definitions and partial meaning of general terms, water systems, barrier technologies, completion of production of sterile products, environment and process monitoring among several other technological and procedural rules.
Attached files
Web site
Date of text
Entry into force notes
This text entered into force on the day of its publication in the Official Gazette (published on 1 March 2024), with the exception of the amendments article 2, item 8.123 of section I "Manufacturing of sterile veterinary medicinal products", chapter three "Additional requirements for the production of various categories veterinary medicinal products", which shall enter into force on 25 August 2024.
Repealed
No
Publication reference
Official Gazette of the Republic of Bulgaria 18/2024
Source language
English
Legislation Amendment
No
Original title
Наредба за изменение и допълнение на Наредба № 69 от 2006 г. за изискванията за Добрата производствена практика при производство на ветеринарномедицински продукти и активни субстанции.